The Recall Desk
ModerateFDA (Devices)·Z-0847-2016·Announced 2016-03-02

Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion

Zimmer Biomet is recalling 101 Versus 7.5 inch hip prostheses because the LDPE packaging bag adheres to the implant surface.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a packaging adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 101 units of the VERSYS 7.5 INCH BEADED FC prosthesis, a semi-constrained total hip replacement device. The recall affects specific item numbers and lot numbers distributed worldwide, including the United States and numerous international markets.

The recall was initiated because the LDPE bag containing the implant adheres to the highly polished implant surface. This packaging defect may compromise the integrity of the device or its sterile barrier.

Healthcare providers and patients who have received these specific hip prostheses should contact Zimmer Biomet for further instructions on how to proceed. The affected units are identified by the specific item and lot numbers listed in the official recall notice.

The recalled product

Product
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascula
Affected units
101

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →